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临床试验/NCT05688670
NCT05688670已完成4 期

Pain Control With Regional Anesthesia Following Pediatric Cardiac Surgery: A Randomized Double-Blinded Pilot Study

Duke University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年3月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
52
试验地点
1
主要终点
Total Amount of Opioid Medications Administered

研究概览

简要总结

The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.

详细描述

This is a single center, randomized, double blind investigation which will compare postoperative pain control indices, functional recovery metrics and patient/parental satisfaction for pediatric patients receiving an ultrasound guided regional anesthetic versus surgeon delivered wound infiltration in children undergoing primary atrial and ventricular septal defect repairs. Surgical and anesthesia care, with the exception of the technique of local anesthetic administration, are not altered for study purposes. Subjects are randomized 1:1 to either bilateral Pecto-Intercostal Fascial Block and unilateral Rectus Sheath Block or infiltration of the wound through the perioperative period. Both interventions will use an equal volume of Ropivacaine 0.2% based on weight. Exploratory data will be collected for up to 30 days postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children less than 18 years old
  • Presenting for primary atrial septal defect or ventricular septal defect repair
  • Informed consent / assent provided

排除标准

  • Patients on opioid therapy at the time of surgery
  • History of sternotomy
  • Planned postoperative intubation
  • Current diagnosis of a chronic pain syndrome.

研究组 & 干预措施

Regional Anesthesia

Active Comparator

Ultrasound guided blocks

干预措施: Regional Anesthesia (Procedure)

Regional Anesthesia

Active Comparator

Ultrasound guided blocks

干预措施: Ropivacaine 0.2% Injectable Solution (Drug)

Wound Infiltration

Active Comparator

Surgeon-delivered wound infiltration

干预措施: Wound infiltration (Procedure)

Wound Infiltration

Active Comparator

Surgeon-delivered wound infiltration

干预措施: Ropivacaine 0.2% Injectable Solution (Drug)

结局指标

主要结局

Total Amount of Opioid Medications Administered

时间窗: Up to 12 hours after surgery

Postoperative opioid medication expressed in morphine equivalents per kilogram

次要结局

  • Total Amount of Opioid Medications Administered(Up to 48 hours after surgery)
  • Postoperative Pain Intensity AUC(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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